Combined corticosteroid and long-acting beta-agonist versus corticosteroid for moderate/severe chronic obstructive pulmonary disease. A double blind, randomized, multicenter, phase III study.

In adults with Chronic Obstructive Pulmonary Disease (COPD), is corticosteroid combined with long-acting beta-agonist effective in forced expiratory volume in one second (FEV1) values, as compared to corticosteroid?

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000850279

Enrollment

136

Registered

2009-10-01

Start date

2010-04-30

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

In adults with Chronic Obstructive Pulmonary Disease (COPD) the study will compare the efficacy of a corticosteroid combined with long-acting beta-agonist effective in forced expiratory volume in one second (FEV1) values, as compared to corticosteroid. The hypothesis will consider the superiority of the combination therapy.

Interventions

Two arms: 1)Fluticasone 500 micrograms +Formoterol 12 micrograms, twice a day, for 12 weeks; capsule for inhalation 2)Fluticasone 500 micrograms, twice a day, for 12 weeks; capsule for inhalation

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

moderate or severe COPD according to GOLD (Global Initiative for Chronic Obstructive Lung Disease) smoker or former smoker

Exclusion criteria

Hospitalization due to COPD up to 4 weeks before screening visit Subjects who have required treatment with oral corticosteroids, anti-leukotriene, immunoglobulins, beta-blockers, digitalis, itraconazole 2 months prior to Visit 1

Outcome results